DePuy, Inc.; Premarket Approval of the Rotating Platform Configuration of the New Jersey LCSRegister Total Knee System

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application by DePuy, Inc., Warsaw, IN, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Rotating Platform Configuration of the new jersey LCS Total Knee System. After reviewing the recommendation of the Orthopedic and Rehabilitation Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of February 24, 1994, of the approval of the application.